Plastikon Healthcare LLC recalls Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 30 mL cup, packaged in 10 cups pe
Recalled September 14, 2022 · FDA recall D-1482-2022 · Plastikon Healthcare
Hazard
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. · FDA Class II
Units
521,700 cups
Sold at
Distributed Nationwide in the USA
Description
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Product
Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6838-73
Manufacturer(s)
Plastikon Healthcare LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →